Nick's career in the pharmaceutical industry began in 1997 and since then his roles have spanned international regulatory affairs and strategy, GxP activities, e-Submissions and laboratory roles in pharmaceutical chemistry and manufacturing.
Following studies in industrial chemistry, Nick enjoyed a variety of laboratory roles over a seven year period including stability monitoring, manufacturing process validation and analytical method development and validation. During this time he led teams to complete analytical studies and the resulting reports for submission to global agencies. In 2005 Nick moved to the UK and began his career in European regulatory affairs where he coordinated marketing authorisation applications to various European authorities. Upon his return to Australia, Nick led a regulatory affairs team responsible for writing, publishing and submitting CTD dossiers for generic products to Europe, USA, SE Asia and Australia.
In 2009 Nick co-founded Pharma To Market with Johanna where they work with clients locally and around the globe to bring pharmaceutical and biological products to the Australian and New Zealand markets. Since establishing Pharma To Market, Nick, Jo and their team have successfully managed numerous new marketing authorisation applications on behalf of clients. Nick’s experience covers a wide range of therapeutic areas and dosage forms, including new chemical and biological entities. Nick provides his clients with effective regulatory strategies, and often represents clients at pre-submission meetings; he also has hands on experience with orphan drug designation applications and literature based submissions.